Event Description

Overview:Phase I clinical trials are the first time that investigational new drugs are introduced into human subjects and, although it is very, very important for all drugs to be manufactured using GMPs, it is probably more important than at any other time during the lifecycle of the product, that a product be safe whenever humans are being exposed to it for the first time.

Why should you Attend:FDAs guidance document "Good Manufacturing Practice for Phase I Investigational Drug Products" applies to correct GMP requirements to drug products made for the purpose of using an investigational drug product on human subjects for the first time, during conduct of Phase I clinical trials, which can begin if your IND is not put on clinical hold in 30 days after receipt by the FDA.

Areas Covered in the Session:Statutory and Regulatory RequirementsPersonnel requirementsQC FunctionsFacility and Equipment RequirementsControl of Components and Containers and ClosuresManufacturing and Records